A Study Of Avelumab In Combination With Axitinib In Advanced Renal Cell Cancer (JAVELIN Renal 100)

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This is a Phase 1b, open-label, multi-center, multiple-dose trial designed to estimate the maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D) of avelumab (MSB0010718C) in combination with axitinib (AG-013736). Once the MTD of avelumab administered in combination with axitinib is estimated (dose finding portion), the dose expansion phase will be opened to further characterize the combination in term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and biomarker modulation.

Number of participant with Dose-Limiting Toxicities (DLT) [ Time Frame: First 4 weeks of treatment ]

DLTs of avelumab in combination with axitinib occurred during the first 4 weeks of treatment

Secondary Outcome Measures :

Number of participants with Objective Response [ Time Frame: Every 6 weeks up to 1 year from start date, then every 12 weeks ]

Number of participants with objective response (ie, confirmed complete or partial response according to RECIST Version 1.1) from the start date until disease progression or death due to any cause.

Duration of response (DR) [ Time Frame: Every 6 weeks up to 1 year from start date, then every 12 weeks ]

DR is the time from the first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the first documentation of objective tumor progression or to death due to any cause.

Progression Free Survival (PFS) [ Time Frame: Every 6 weeks up to 1 year from start date, then every 12 weeks ]

Progression Free Survival (PFS) is the time from the start date to the date of the first documentation of objective progression of disease (PD) or death due to any cause.

Time to Response (TTR) [ Time Frame: Every 6 weeks up to 1 year from start date, then every 12 weeks ]

Time to Tumor Response (TTR) is the time from start date to the first documentation of objective tumor response (CR or PR) that is subsequently confirmed.

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Availability of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met: 1) the biopsy or resection was performed within 1 year of enrollment AND 2) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and enrollment onto the current study. If an FFPE tissue block cannot be provided as per documented regulations,, 15 unstained slides (10 minimum) will be acceptable.

Availability of an archival FFPE tumor tissue block from primary diagnosis specimen (if available and not provided per above). If an FFPE tissue block cannot be provided, 15 unstained slides (10 minimum) will be acceptable

At least one measureable lesion as defined by RECIST version 1.1 that has not been previously irradiated.

Age ≥18 years (≥ 20 years in Japan).

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Adequate bone marrow function, renal and liver functions

Exclusion Criteria:

Prior systemic therapy directed at advanced RCC.

Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment